Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.

Ketamine

Brief Summary

Thoracotomy for lung resection is deemed painful. Ketamine is now a renewed interest in preventing acute postoperative pain. A previous study performed in the service testing the association ketamine/morphine versus morphine PCA, postoperative, for patients who do not benefit from postoperative epidural thoracic surgery, has demonstrated a reduction of postoperative pain associated with a reduction of nocturnal arterial desaturation following surgery when ketamine was added to morphine.

Intervention / Treatment

  • Ketamine (DRUG)
    ketamine with various concentrations
  • Placebo (DRUG)
    physiological serum

Condition or Disease

  • Thoracotomy

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 85 Years
    Enrollment: 21 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Mar 01, 2008
    Primary Completion: Jul 01, 2010 ACTUAL
    Completion Date: Dec 01, 2010 ACTUAL
    Study First Posted: Jul 31, 2008 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 27, 2014

    Sponsors / Collaborators

    Lead Sponsor: Assistance Publique Hopitaux De Marseille
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Marseille, Provence-Alpes-Côte d'Azur, France

    In this prospective double blind randomized study, intravenous administration of an analgesic dose of ketamine was started since the induction of general anesthesia and continued during the first 48 postoperative hours in association with epidural analgesia.

    Participant Groups

    • Drip of physiological serum

    • Drip of ketamine

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 85
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Subject between 18 and 85 years
    * subject of both sexes
    * subject operated in the service of thoracic surgery of a lobectomy by thoracotomie lateral or postlaterale subject
    * subject operated in settled surgery

    Exclusion Criteria:

    * Against indication in the epidural insanity,
    * confusionnel, patient psychotic
    * treatment in the long price by medicine which can interfere on the pain (morphine, antidepressants, psychotropic treatment)

    Primary Outcomes
    • To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural 24 months
    Secondary Outcomes
    • To estimate the effect of the association ketamine IV thoracic epidural on the postoperative pain postponed in 1, 3 and 6 months 24 months
    • To estimate the effect of the association ketamine IV thoracic epidural on the incidence of the urinary side effects and hémodynamiques of the epidural 24 months

    More Details

    NCT Number: NCT00726258
    Other IDs: 2007-00336-20
    Study URL: https://clinicaltrials.gov/study/NCT00726258
    Last updated: Sep 29, 2023